BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1070591 · Received July 2, 2008

    Report

    Report Number
    2210968-2008-00500
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2008. DURING THE PROCEDURE, THE BALLOON BURST AFTER SIX MINUTES OF THERAPY. THE CONTROLLER UNIT TURNED OFF AUTOMATICALLY AND THE PROCEDURE WAS ABORTED. THERE WAS NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK